Type2 DiabetesNCT04547790
A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2
A study testing Psyllium and Wheat Dextrin in people with Type2 Diabetes, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine which of Psyllium and Wheat Dextrin is more effective in lowering fasting blood sugar and hemoglobin A1c, and to evaluate the effects they have on laboratory values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Psyllium and Wheat Dextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2020to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- May be on oral therapy (including metformin) or insulin
- Most recent HgbA1c level measuring between 6.5 -10 within the last 3 months
- May be on stable (> 4 weeks) statin dose or no statin therapy
- Willing to sign informed consent and stay on current medical regimen
- Does not use regular dietary fiber supplements; has not had any psyllium containing products in the previous 30 days; is willing to refrain from taking any other fiber containing supplement products during the study
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- Has not used systemic steroid agents in the last 30 days
- Able to participate fully in all aspects of the study
- Have access and ability to utilize text messaging or email
Who cannot join
- Unwilling/unable to participate
- Comorbid inflammatory bowel disease, celiac sprue, nephrotic syndrome, severe cholestasis (e.g., primary biliary cirrhosis), or history of bariatric surgery/bowel resection
- Alcohol use in excess of 14 drinks/week
- Allergic reactions to psyllium or wheat dextrin
- Has participated in a clinical drug study or used an investigational new drug during the previous 30 days
- Self-Report of known or suspected pregnancy or immediate plans (within 3 months) of becoming pregnant
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- Currently breastfeeding
- Has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
- Anticipated or recent major changes in diet or exercise routine
- Anticipated colonoscopy prep during 3 months of study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Fiber and Diabetes (FAD) Study: Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markers in DM2
The purpose of this study is to determine which of Psyllium and Wheat Dextrin is more effective in lowering fasting blood sugar and hemoglobin A1c, and to evaluate the effects they have on laboratory values.
Read the detailed description
Patients identified as Type 2 diabetics will be identified via Mayo's electronic data system and verified by review of their medical record. Study coordinators will then send invitation letters to patients who meet initial inclusion criteria via mail or through the Mayo Patient Online Services (i.e. patient portal). Recruitment tools used will be flyer, an internet web posting, and a Mayo classified research ad placed in the Mayo classifieds. If patients are interested in participating, they will call or email the study coordinators to set up their baseline visit. Non-responders will be called up to 3 times if no answer. The study coordinator will ask if they received the letter and if they have any questions and if they are interested in participating.
Potential subjects will be screened and consented either digitally or via paper. After consent, the study coordinator will complete the subject's medical history, review concomitant medications, and record vital signs during the baseline visit. Subjects will be randomized and instructed to complete a baseline blood draw, after which they will be given a 3-month supply of study product, a dosing scoop for the product and instructions on taking the assigned study product. They will be assigned to take the study product once daily for the first three days, then twice daily starting Day 4 until the end of the study.
Subjects will be asked to respond to a text message or email message, daily, asking how many doses of study medication they took for that day (0, 1 or 2). The study coordinator will also contact subjects by phone or email to review and reinforce adherence to the protocol if the survey research center identifies subjects who have not responded to text messages within 3 days.
Subjects will meet with study coordinators in person at 4, 8, and 12 weeks or study end to collect vitals, perform a symptom check, review concomitant medications, complete blood draws, and reinforce adherence to protocol.
- Conditions
- Type2 Diabetes
- Being tested
- Psyllium, Wheat Dextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumDietary supplement
Also called Metamucil
One level scoop (12.5mL) of 5.1g of psyllium fiber twice a day with 8 ounces water
Wheat DextrinDietary supplement
Also called Benefiber
One level scoop (12.5 mL) of 1.7g wheat dextrin fiber twice a day with 8 ounces water
| Study group | Role | What they receive |
|---|---|---|
| Psyllium group | Experimental | Subjects will take psyllium once daily for the first three days, then twice daily starting Day 4 until the end of the study. Receives: Dietary Supplement: Psyllium |
| Wheat Dextrin group | Experimental | Subjects will take wheat dextrin once daily for the first three days, then twice daily starting Day 4 until the end of the study. Receives: Dietary Supplement: Wheat Dextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood sugar
The two endpoints of primary interest for this study are HbA1c and fasting glucose. The primary analysis will assess the change in these endpoints between the two treatment groups over the 12 week study period. To estimate the difference between study groups a linear mixed model will be used to account for repeated measures of subjects. The independent variable will be Psyllium group and the baseline outcome result will be included as a covariate.
Measured: 12 weeks
Change in HbA1c
The primary analysis will assess the change in these endpoints between the two treatment groups over the 12 week study period. To estimate the difference between study groups a linear mixed model will be used to account for repeated measures of subjects. The independent variable will be Psyllium group and the baseline outcome result will be included as a covariate.
Measured: 12 weeks
Secondary outcomes (4)
Change in LDL-C
As a secondary analysis, LDL-C, will be collected and analyzed. to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate.
Measured: 12 weeks
Change in ceramides
As a secondary analysis, ceramides will be collected and analyzed to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate.
Measured: 12 weeks
Change in blood pressure
Blood pressure will be collected and analyzed. For vital signs measurements a paired t-test will be used to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate.
Measured: 12 weeks
Change in weight
Weight will be collected and analyzed. For vital signs measurements a paired t-test will be used to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start23 Dec 2020
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen L. Kopecky, Mayo Clinic
- Investigators
- Stephen Kopecky, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547790
- Sponsor's protocol ID
- 19-010612
- Status last verified
- Mar 2024
- First submitted
- 8 Sep 2020
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber and Diabetes (FAD) Study: Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markers in DM2
- ClinicalTrials.gov ID
- NCT04547790
- Acronym / sponsor ID
- 19-010612
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine which of Psyllium and Wheat Dextrin is more effective in lowering fasting blood sugar and hemoglobin A1c, and to evaluate the effects they have on laboratory values.
Detailed description
Patients identified as Type 2 diabetics will be identified via Mayo's electronic data system and verified by review of their medical record. Study coordinators will then send invitation letters to patients who meet initial inclusion criteria via mail or through the Mayo Patient Online Services (i.e. patient portal). Recruitment tools used will be flyer, an internet web posting, and a Mayo classified research ad placed in the Mayo classifieds. If patients are interested in participating, they will call or email the study coordinators to set up their baseline visit. Non-responders will be called up to 3 times if no answer. The study coordinator will ask if they received the letter and if they have any questions and if they are interested in participating.
Potential subjects will be screened and consented either digitally or via paper. After consent, the study coordinator will complete the subject's medical history, review concomitant medications, and record vital signs during the baseline visit. Subjects will be randomized and instructed to complete a baseline blood draw, after which they will be given a 3-month supply of study product, a dosing scoop for the product and instructions on taking the assigned study product. They will be assigned to take the study product once daily for the first three days, then twice daily starting Day 4 until the end of the study.
Subjects will be asked to respond to a text message or email message, daily, asking how many doses of study medication they took for that day (0, 1 or 2). The study coordinator will also contact subjects by phone or email to review and reinforce adherence to the protocol if the survey research center identifies subjects who have not responded to text messages within 3 days.
Subjects will meet with study coordinators in person at 4, 8, and 12 weeks or study end to collect vitals, perform a symptom check, review concomitant medications, complete blood draws, and reinforce adherence to protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psyllium group | Experimental | Dietary Supplement: PsylliumSubjects will take psyllium once daily for the first three days, then twice daily starting Day 4 until the end of the study. |
| Wheat Dextrin group | Experimental | Dietary Supplement: Wheat DextrinSubjects will take wheat dextrin once daily for the first three days, then twice daily starting Day 4 until the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18
- May be on oral therapy (including metformin) or insulin
- Most recent HgbA1c level measuring between 6.5 -10 within the last 3 months
- May be on stable (> 4 weeks) statin dose or no statin therapy
- Willing to sign informed consent and stay on current medical regimen
Key exclusion criteria (10 listed)
- Unwilling/unable to participate
- Comorbid inflammatory bowel disease, celiac sprue, nephrotic syndrome, severe cholestasis (e.g., primary biliary cirrhosis), or history of bariatric surgery/bowel resection
- Alcohol use in excess of 14 drinks/week
- Allergic reactions to psyllium or wheat dextrin
- Has participated in a clinical drug study or used an investigational new drug during the previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsylliumAlso: MetamucilOne level scoop (12.5mL) of 5.1g of psyllium fiber twice a day with 8 ounces water | Dietary supplement | Psyllium group |
| Wheat DextrinAlso: BenefiberOne level scoop (12.5 mL) of 1.7g wheat dextrin fiber twice a day with 8 ounces water | Dietary supplement | Wheat Dextrin group |
Primary outcome
Change in fasting blood sugar
Time frame: 12 weeks
The two endpoints of primary interest for this study are HbA1c and fasting glucose. The primary analysis will assess the change in these endpoints between the two treatment groups over the 12 week study period. To estimate the difference between study groups a linear mixed model will be used to account for repeated measures of subjects. The independent variable will be Psyllium group and the baseline outcome result will be included as a covariate.
Change in HbA1c
Time frame: 12 weeks
The primary analysis will assess the change in these endpoints between the two treatment groups over the 12 week study period. To estimate the difference between study groups a linear mixed model will be used to account for repeated measures of subjects. The independent variable will be Psyllium group and the baseline outcome result will be included as a covariate.
4 secondary outcomes
Change in LDL-C
Time frame: 12 weeks
Change in ceramides
Time frame: 12 weeks
Change in blood pressure
Time frame: 12 weeks
Change in weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kopecky, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium and Wheat Dextrin in people with Type2 Diabetes, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting blood sugar (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.